Informed consent in the RD-Connect platform: preparing guidelines for the information of participants/donors

The Rd-Connect project aims at building up a platform for the linking and exchange of data among researchers working in the field of rare diseases (RD), in particular in RD patient registries, biobanks and bioinformatics. The increase in registration activities and data sharing provides unique opportunities in RD research, but it also brings new challenges in balancing a patient’s right to privacy and integrity. Informed consent and the review of research protocols by a research ethics committee are the standard ways adopted by modern societies to warrant validity of research, respect for persons and their autonomy. However, both process can be costly and time consuming, especially in retrospective research when re-conset of all subjects may be difficult to achieve. In Rd-Connect a discussion on the best models for informed consent has been undertaken by researchers, RD patients, health institutions and industry representatives. The ongoing debate started in Brussels during the Stakeholder Conference (21 and 22 October 2013) and will continue in Rome, during a workshop detailing consent guidelines (23 and 24 April 2014).